The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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11551–11575 of 13816

  • HighFDA (Devices)·Z-1352-2022·2022-07-20

    MiniMed 620G insulin pump battery cap deterioration may cause power loss

    Medtronic MiniMed 620G insulin pumps may experience battery cap deterioration, resulting in incomplete battery circuit and loss of power. Approximately 2,287 affected pumps have been distributed across the U.S.

    Product
    MiniMed 620G Insulin Pump (O.U.S. version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1371-2022·2022-07-20

    Hemodialysis Dialysate Recalled for Unqualified Bottle Caps

    Fresenius Medical Care is recalling NATURALYTE Liquid Acid dialysate because bottle caps are not qualified for use. The recall affects 163 cases of lot 22CTAC102 distributed nationwide.

    Product
    NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1346-2022·2022-07-20

    CoolMax ZELTIQ Vacuum Applicator recalled for paradoxical hyperplasia complaints

    Zeltiq Aesthetics is voluntarily discontinuing 2,945 CoolMax ZELTIQ Vacuum Applicators due to an increase in paradoxical hyperplasia complaints between 2019 and 2021, an adverse event causing unwanted tissue growth instead of intended fat reduction.

    Product
    CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1367-2022·2022-07-20

    Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions

    Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.

    Product
    Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2022·2022-07-20

    Isopure IsoMix PRO Mixing System Electrical Short Recall

    Isopure is recalling approximately 119 units of the Sodium Bicarbonate Mixing and Distribution System due to an electrical short causing a thermal event and device damage. No injuries reported.

    Product
    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1358-2022·2022-07-20

    MiniMed 770G Insulin Pump Battery Cap May Deteriorate, Causing Power Loss

    Medtronic is recalling MiniMed 770G insulin pumps because battery cap deterioration may cause power loss and insulin delivery failure. Approximately 123,585 units are affected.

    Product
    MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1347-2022·2022-07-20

    CoolCore ZELTIQ Vacuum Applicator Voluntarily Recalled Due to Paradoxical Hyperplasia

    Zeltiq Aesthetics is voluntarily recalling CoolCore ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia, an adverse effect causing unwanted fat tissue growth. The recall affects 3,054 units distributed across the U.S. and internationally.

    Product
    CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1374-2022·2022-07-20

    Ventana HE 600 Automated Slide Preparer Recalled for Potential Electrical Fire Risk

    Ventana Medical Systems is recalling 763 Ventana HE 600 automated slide preparer instruments used in laboratories worldwide due to potential fluid leaks that could cause electrical shorts and fire.

    Product
    Ventana HE 600 System, automated slide preparer, for use in laboratories.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1328-2022·2022-07-20

    Radiography system firmware bug may cause incorrect radiation doses

    Certain Philips DigitalDiagnost C90 X-ray systems contain a firmware defect that can cause incorrect radiation doses and misaligned anatomic position markers when using the Wallstand VS2 board.

    Product
    DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1384-2022·2022-07-20

    Anti-FITC-AP CISH Kit Label Bears Incorrect Expiration Date

    Agilent Technologies is recalling 63 Anti-FITC-AP CISH Accessory Kits due to incorrect expiration dates on substrate vial labels, which may result in the use of expired materials.

    Product
    Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1375-2022·2022-07-20

    Cathcart Hip Ball prosthesis recalled for missing surgical technique specification

    DePuy Orthopaedics is recalling Modular Cathcart Hip Ball prostheses (sizes 41-60mm) because the Instructions for Use and Surgical Technique Guide did not document a +5mm offset specification. Updated guides now clarify this for hemi-hip arthroplasty procedures.

    Product
    MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1361-2022·2022-07-20

    Medical device manufacturer recalls mislabeled interference screws nationwide

    SCIENCE & BIO MATERIALS has recalled ComposiTCP 30 Interference screws due to mislabeling. The recall affects 72 units distributed nationwide in the US.

    Product
    ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1369-2022·2022-07-20

    Invacare Platinum 5NXG Oxygen Concentrator Recall Due to Missing Rx Only Label Statement

    Invacare Corporation is recalling 179 Platinum 5NXG Oxygen Concentrator units distributed across 18 states because product labels are missing the required "Rx Only" statement.

    Product
    Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1351-2022·2022-07-20

    Philips LAS-100 Laser System may not operate due to detected hardware failure

    Spectranetics' Philips LAS-100 Laser System (105 units) may fail to start if the device detects an inoperable hardware component during power-up, requiring manual error code clearing before operation.

    Product
    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
    Category
    Medical Device
    Distribution
    27 states
  • CriticalFDA (Devices)·Z-1319-2022·2022-07-13

    Palindrome HSI Chronic Catheter Recalled for Potential Hub Leaking

    Covidien is recalling Palindrome HSI Chronic Catheters due to a potential leaking condition in the catheter hub that may cause unanticipated fluid return during dialysis. Approximately 13,526 units distributed worldwide are affected.

    Product
    Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1276-2022·2022-07-13

    Clean Catch Urine Kit Recalled Due to Improper Assembly

    American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.

    Product
    Clean Catch Urine Kit NS 178489, AHMU58A
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1313-2022·2022-07-13

    Palindrome Precision H Chronic Catheter Recalled for Potential Hub Leakage

    Covidien is recalling certain Palindrome Precision H Chronic Catheters because the hub may leak, causing unexpected fluid to flow back during use. This FDA Class I recall affects 26,675 units distributed globally.

    Product
    Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1314-2022·2022-07-13

    Palindrome Precision SI Chronic Catheters Recalled for Potential Hub Leaking

    Covidien recalls Palindrome Precision SI chronic dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use.

    Product
    Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1317-2022·2022-07-13

    Palindrome H Chronic Catheters Recalled for Potential Hub Leaking

    Palindrome H Chronic Catheters are being recalled due to a potential leaking condition in the catheter hub that may result in unanticipated fluid return during hemodialysis treatment. Affected units have been distributed worldwide.

    Product
    Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1315-2022·2022-07-13

    Palindrome Precision Chronic Dialysis Catheters Risk Fluid Leakage Due to Hub Defect

    Covidien recalls 25,765 Palindrome Precision HSI Chronic Catheters due to a defect in the hub that may cause unintended fluid leakage during dialysis treatment.

    Product
    Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1277-2022·2022-07-13

    COVID-19 nasopharyngeal sample collection tray recalled due to improper assembly

    American Contract Systems, Inc. recalls 274,400 COVID-19 test kits distributed in Minnesota due to off-site assembly by individuals who may not have been properly trained.

    Product
    Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1312-2022·2022-07-13

    Palindrome Precision Chronic Dialysis Catheter Hub Leak Risk

    Palindrome Precision Chronic Catheters used for dialysis may leak due to a flaw in the hub component, potentially allowing unintended fluid to escape during treatment.

    Product
    Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1316-2022·2022-07-13

    Palindrome Chronic Catheter recalled due to potential hub leakage

    Covidien is recalling Palindrome Chronic Catheters due to a potential leaking condition in the hub that may cause unexpected fluid return during use.

    Product
    Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide